Sr SW Design Quality Engineer

Regulatory Toolkit; United States; Hybrid; USD 96,000 - 160,000; Full time

Benefits offered by this job

CGM tech access

Benefits program

Global growth

Learning programs

Innovative company

Job summary

Dexcom Corporation seeks a Senior Software Design Assurance Engineer to guide software quality for cloud‑based data platforms and AI/ML‑enabled systems in a regulated environment.

The role focuses on design assurance across the SDLC, risk analysis, regulatory compliance, and post‑market activities. Strong collaboration with cross‑functional teams and leadership is essential.

Qualifications

• Typically requires a Bachelor’s degree in a technical discipline and 5–8 years related experience.
• Experience with software design assurance in regulated environments.
• Knowledge of IEC 62304 and FDA 21 CFR Part 820 applicability.
• Experience with cloud-based data platforms and AI/ML-enabled systems.

Responsibilities

• Act as a core member of R&D Quality Assurance Engineering for cloud‑based data platforms, API, and AI/ML‑enabled systems.
• Provide hands‑on guidance on IEC 62304, 21 CFR 820, and global regulations for SaaS, data, and AI products.
• Lead software design assurance practices across the SDLC for distributed/cloud services.
• Drive pre‑market risk management deliverables (SHA, design FMEA, risk controls).
• Guide teams on requirements traceability, configuration management, tool validation, and integration.
• Review and approve design control deliverables to ensure regulatory compliance and product quality.
• Support post‑market activities related to anomalies, risk assessments, and CAPA.
• Author and maintain DHFs, SOPs, protocols, and reports for cloud and AI/ML systems.
• Assess change control for infrastructure/data/model changes to maintain compliant state.
• Communicate plans, progress, risks to cross‑functional teams and leadership.

Skills

IEC 62304

FDA 21 CFR Part 820

ISO 13485

ISO 14971

Cloud-based systems

Education

Bachelor's degree in a technical discipline

Master's degree

PhD

Job description

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.

We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

Job Description

*This is NOT a test role*

The Senior Software Design Assurance (Sr Software Design Quality) Engineer provides technical support and guidance to Software teams to ensure conformance to software development process and other applicable safety and quality system regulation and standards (e.g. IEC 62304, ISO 13485, ISO 14971).

This role will be responsible for various aspects of Software Design Assurance with a focus on product improvement, new product development, and defect prevention. This position will interface with different cross functional groups (Software Engineering, Software Test, Regulatory Affairs, Marketing, Project managers, Systems Engineering, Cybersecurity, and others). A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.

*This is NOT a test role*

Where you come in:

• You will actively participate as a core member of the R&D Quality Assurance Engineering team, supporting software design assurance for cloud‑based, data platform, and AI/ML‑enabled systems.

• You will provide hands‑on technical guidance to cross‑functional teams on IEC 62304, 21 CFR 820, and other applicable global regulations for software‑as‑a‑service, data, and AI‑driven products.

• You will lead the effective application, compliance, and continuous improvement of software development and validation practices for distributed systems, cloud services, and data platforms.

• You will drive pre‑market risk management deliverables, including Software Hazard Analysis (SHA), design FMEA, and risk controls related to cloud infrastructure, data processing, and AI/ML functionality.

• You will guide Software Design and Test teams on software design assurance activities such as requirements traceability, software configuration management, tool validation, and integration of cloud and data services.

• You will review and approve software design control deliverables associated with cloud‑hosted services, data pipelines, and AI/ML components to ensure regulatory compliance and product quality.

• You will support post‑market activities related to software anomalies, model behavior, data quality issues, risk assessments, and CAPA activities, as applicable.

• You will author, review, and maintain technical documentation including Design History Files, SOPs, protocols, and reports for cloud‑based and AI/ML‑enabled systems.

• You will assess change control activities related to infrastructure, data, or model changes to ensure no adverse impact to product performance and to maintain a compliant state.

• You will effectively communicate plans, progress, risks, and design assurance considerations to cross‑functional teams and senior leadership.

What makes you successful:

Nice to have: AI/ML experience or ASQ CSQE certification.

• You bring strong experience in software design assurance for cloud‑based, data platform, API, and service‑oriented systems in a regulated environment.

• You have demonstrated hands‑on knowledge of IEC 62304, FDA 21 CFR Part 820, ISO 13485, and their application to software‑as‑a‑service and data‑driven products.

• Your proficiency includes applying software design assurance principles across the SDLC, including requirements analysis, architecture and design reviews, implementation oversight, integration, and verification.

• You have experience performing and reviewing software risk management activities, including Software Hazard Analysis (SHA), design FMEA, and change impact assessments for cloud, data, and AI/ML components.

• You are skilled at reviewing and approving software design control deliverables to ensure traceability, risk control implementation, and regulatory compliance.

• You have experience supporting software configuration management, tool validation, and integration of cloud services, data pipelines, and platform components.

• You communicate effectively with cross‑functional partners and can clearly present design assurance, risk, and compliance topics to technical teams and senior leadership.

What you’ll get: (this section should not be modified)

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.

• A full and comprehensive benefits program.

• Growth opportunities on a global scale.

• Access to career development through in-house learning programs and/or qualified tuition reimbursement.

• An exciting and innovative, industry‑leading organization committed to our employees, customers, and the communities we serve.

Travel Required:

• 5-15%

Experience and Education Requirements:

• Typically requires a Bachelor’s degreein a technical discipline, and a minimumof 5-8 years related experience orMaster’s degree and 2-5 yearsequivalent industry experience or a PhDand 0-2 years experience

Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option

Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [e-mail].

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [e-mail].

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Salary:

$95,900.00 - $159,900.00

#DexcomUS